Roflumilast Formulations Show Favorable Tolerability Across Several Trials: Analysis

January 29, 2024

Cream or foam formulation both demonstrated tolerability at all timepoints.

Investigator- and patient-rated assessments indicated that topical roflumilast was tolerable and did not cause discomfort, according to a new analysis of data from several clinical trials.

“Formulating a topical medication that does not irritate the skin is an important factor contributing to patient treatment adherence and satisfaction,” the authors wrote in their abstract. “Many topical prescription products use penetration enhancers (including propylene glycol, polyethylene glycol, and ethanol) to overcome barrier properties of the skin. However, these excipients may irritate the skin causing tolerability reactions such as burning and stinging, which can reduce patient treatment adherence.”

The analysis included prospectively assessed investigator- and patient-rated local tolerability from a group of phase 3 trials of topical roflumilast in psoriasis patients (DERMIS-1, DERMIS-2, ARRECTOR), seborrheic dermatitis (SD; STRATUM), and atopic dermatitis (AD; INTEGUMENT-1, INTEGUMENT-2). The study team randomized participants to topical roflumilast or to vehicle once daily for 8 weeks (as in the DERMIS, ARRECTOR, and STRATUM studies) or 4 weeks (INTEGUMENT study). Investigators used an 8-point scale (with 0 as no evidence of irritation up to 7 as strong reaction spreading beyond the site of application) for assessment, and patients reported tolerability on a 4-point scale (with 0 as no sensation and 3 as severe, hot, tingling/stinging sensation that causes discomfort).

The majority of patients (≥96.5%) in roflumilast treatment arms experienced no irritation at the application site across the studies. Tolerability was favorable and improvement was reported across trials, and adverse events were also low.

“Roflumilast cream and foam formulations demonstrated favorable local tolerability based on investigator- and patient-rated assessments in patients with psoriasis, seborrheic dermatitis and atopic dermatitis, including in patients with involvement in sensitive areas such as the face, genitals, and intertriginous areas,” the authors wrote in their poster. “Local tolerability was favorable across timepoints and improved with treatment, regardless of indication, cream or foam formulation, or roflumilast concentration.”

Source: Bunick C, Bhatia N, Del Rosso J, et al. Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. Abstract 12611. Presented at: Maui Derm, January 22-26, 2024.


This study was sponsored by Arcutis Biotherapeutics, Inc.

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